Oncology

Breast Cancer

In 2022, an estimated 287,850 women in the United States were diagnosed with invasive breast cancer: approx. 43,250 deaths. And about 1 in 8 American women will develop invasive breast cancer over the course of her lifetime.
Breast cancer is a multifactorial, heterogeneous disease that requires a clinical, multidisciplinary approach to diagnose and manage. At present, diagnosing breast cancer relies primarily on mammography, which has saved numerous lives but also generated controversy due to the risk of false-positive results and overdiagnosis of indolent disease.
We have progressed enough to identify biochemical markers to diagnose and manage breast cancer. While the FDA has approved markers like CA 15-3, CA 27-29, and HER−2, they lack sensitivity for early cancer detection.
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Our approach

Based on the current breast cancer paradigm, it is thought that a single biomarker is not sufficient to detect DCIS in early stages. However, our discovery of a single, powerful cancer biomarker coupled with the limitations of current diagnostic approaches has led Halcyon to develop several technologies that detect early-stage cancer to monitor cancer progression and inform treatment efficacy.
The problem

Serum biomarkers for early detection of breast cancer

Solving for Sensitivity
CA 15-3, the most commonly used breast cancer biomarker, has a low sensitivity of 10% for the detection of early stage tumors.
And although biomarkers such as the soluble form of MUC1 protein (CA 15-3, CA 27-29), MUC16 (CA 125), carcinoembryonic antigen (CEA), and circulating cytokeratin fragments have been suggested as diagnostic markers, they lack sensitivity for early disease detection.

Innovating At-Home Detection

Due to cancer diagnostic limitations, including patient costs and poor sensitivity, as well as a lack of innovation regarding serum biomarker technology, it is of high importance to develop new technologies that can detect early-stage cancer, monitor cancer progression, and enhance treatment effectiveness.
Our discovery that overexpression of GASP-1 is involved in breast cancer initiation, progression, and invasion provides the first example of a single biomarker that can accurately detect the early stages of breast cancer and trace cancer progression to later stages.
Now, we are developing an at-home solution that anyone, anywhere can purchase and use to detect the presence of any cancerous cells before costly and invasive hospital visits.

Halcyon has discovered a protein-based cancer biomarker for early stage detection.

Development of a universal biomarker test kit for early-stage detection of breast cancer.

Our main goal: to develop an at-home test kit using the GASP-1 protein, which is minimally present in “tumor-free” cells and shows significant overexpression in IHC imagery during cancer progression.
If successful, this would be a cheap, non-invasive method for detecting early-stage breast cancer.

Development of an ELISA assay at-home test product for detection of any cancer.

We will then quantify GASP-1 levels in serum samples from normal individuals and from patients with DCIS (Stage 0), early (Stage I), and late stages of breast cancer (Stages III and IV).
This will allow us to create an ELISA test for early detection of breast cancer that can support assessment of cancer severity.

Development of a precise, digital cancer imaging tool for pathologists.

In parallel, we have built an imaging prototype that very accurately distinguishes between DCIS and cancerous cells using GASP-1 expression in IHC images.
We intend for this tool to enhance both patient and pathologist experience by allowing quicker assessment of any cancer cells and their progression.

We are reimagining cancer and Alzheimer's diagnostics with a patient-first approach.

Products in development

Lynthera’s drug delivery contact lens (DDCL) system employs a proprietary sustained release technology in a silicone hydrogel (SiHy) lens. SiHy materials are known to optimize comfort in lens wearers through higher oxygen permeability, resolving hypoxia and reducing discomfort.
Product
Product
Indication
Active Ingredient
Formulation
  • Naloxone SR
    Naloxone SR
    Opioid overdose & Renarcotization
    Naloxone
    Sustained release soft contact lenses
    Indication:
    Opioid overdose& Renarcotization
    Active Ingredient:
    Naloxone
    Formulation:
    Sustained release soft contact lenses

    An opioid injectable that saves lives and patient care costs.

    Background
    The national opioid epidemic remains a critical public health crisis in the US, representing the 7th leading cause of death nationwide. US state health departments purchase the largest quantities of naloxone - over 70% of the market - and distribute to over 4 million emergency first responders at local levels.
    Patient population
    Naloxone today (i.e.,NARCAN nasal spray) is typically first administered by emergency responders to overdose patients. Additional doses are often needed, and eventually lead to intravenous naloxone in an ER setting. A single injection product that accomplishes both goals WITHOUT hospitalization would be a best-in-class product that saves up to $3.8 billion in healthcare cost savings by replacing hospital visits, which are also resisted by addiction populations, or impractical in rural regions.
    Our solution
    Our injectable naloxone product will use one injection to provide both immediate reversal of opioid overdose, and a sustained NLX dose for protection over the following 8 – 10 hrs to prevent re-narcotization without high- or repeated-dose NLX that would lead to severe adverse events.
  • Dry eye CL
    Dry eye CL
    Dry eye
    Cyclosporine A
    Sustained release soft contact lenses
    Indication:
    Dry Eye
    Active Ingredient:
    Cyclosporine A
    Formulation:
    Cyclosporine A

    Treating a new global epidemic.

    Background
    Dry eye disease (DED) is among the most frequent causes for eye clinician visits.

    DED patients suffer from inadequate lubrication of the eye, which can occur in eyes that produce insufficient tear volume, or tears that evaporate too quickly. Increased inflammation can result, causing further complications and long-term damage. Furthermore, the increasing use of digital devices has been identified as a significant factor contributing to the rise in dry eye cases. Prolonged screen time is associated with reduced blink rates and incomplete blinking, leading to tear film instability and increased evaporation, which are key factors in the development of DED.

    Additionally, the blue light emitted by screens can penetrate deep into the eyes, potentially leading to the formation of free radicals and subsequent cellular damage. Primary treatments include tear film restoration using over-the-counter artificial tear drops, and immunomodulating therapy using prescription cyclosporine-A (CsA) eye drops.
    Patient population
    DED is one of the most common ocular diseases worldwide, with prevalence of up to 50% of the global, adult population and over 16 million Americans officially diagnosed.

    The CDC estimates that 45 million people in the US wear contact lenses. Further, dry eye and related symptoms of irritation are reported by 40% of these wearers, and 25% suffer from moderate to severe symptoms.
    Our solution
    Our DDCL administers the clinically proven dry eye therapeutic cyclosporine A for acute cases of dry eye, particularly among existing contact lens wearers.
  • Allergy DDCL
    Allergy DDCL
    Ocular Allergy
    Olopatadine
    Sustained release soft contact lenses
    Indication:
    Ocular Allergy
    Active Ingredient:
    Olopatadine
    Formulation:
    Sustained release soft contact lenses

    Allergy therapy that actually works.

    Background
    Allergic conjunctivitis (AC) is an inflammatory condition of the ocular conjunctiva resulting from exposure to pollen, animal dander, and environmental stimuli. Topical eye drops containing antihistamines are the primary treatment method, although limited by burst release, low bioavailability, and poor patient adherence. Further, eye drops are not practical for contact lens wearers as contact lenses prevent effective absorption of existing eye drop solutions targeting allergy-related symptoms.
    Patient population
    Over 20% of the U.S. – or approximately 66 million patients – are affected, with wearers of contact lenses (CL) particularly vulnerable due to allergen accumulation on the lens, and restricted tear exchange underneath its surface. Of the 45 million Americans that wear CLs, 40% suffer from allergies causing irritation and disruption of lens wear.
    Our solution
    Using our DDCL technology, we can produce sustained release of olopatadine (OPD) in order to more effectively treat AC. Further, production of our DDCL-OPD will be compatible with existing lens manufacturing operations, including all standard physical specifications and refractive capabilities of current commercial contact lenses, consituting a major improvement over both eye drops and available drug delivery lens technology.
  • Glaucome DDCL
    Glaucome DDCL
    Open-Angle Glaucome
    Bimatropost
    Sustained release soft contact lenses
    Indication:
    Open-Angle Glaucome
    Active Ingredient:
    Bimatropost
    Formulation:
    Sustained release soft contact lenses

    TBD

    Background
    Glaucoma is one of the leading causes of irreversible blindness in the United States, affecting nearly 3m Americans today while costing the US economy $2.86 billion every year in direct costs and productivity losses.
    Patient population
    By 2050, that number is expected to rise to over 6m due to the aging US population.
    Our solution (TBD)
    Using our DDCL technology, we can produce sustained release of olopatadine (OPD) in order to more effectively treat AC. Further, production of our DDCL-OPD will be compatible with existing lens manufacturing operations, including all standard physical specifications and refractive capabilities of current commercial contact lenses, consituting a major improvement over both eye drops and available drug delivery lens technology.
Our Technology

Discover how our cutting-edge drug delivery technology effortlessly enhances your vision and eye health.

Our unique technology

Medication Infusion into Lenses

The Lynthera DDCL platform can load any approved, ocular medication for continuous release into the eye throughout lens wear.

Controlled Release Mechanism

Our controlled release feature allows Lynthera lens wearers to experience consistency in drug delivery, whether for dry eye or allergy.

Enhanced Absorption for Patients

Unlike eye drops and other approved drug delivery systems, Lynthera's DDCL ensures patients maximize the benefits of their ocular medication, leading to better outcomes.
contact

Products in development

Lynthera’s drug delivery contact lens (DDCL) system employs a proprietary sustained release technology in a silicone hydrogel (SiHy) lens. SiHy materials are known to optimize comfort in lens wearers through higher oxygen permeability, resolving hypoxia and reducing discomfort.
Product
Product
Indication
Active Ingredient
Formulation
  • Naloxone SR
    Naloxone SR
    Opioid overdose & Renarcotization
    Naloxone
    Sustained release soft contact lenses
    Indication:
    Opioid overdose& Renarcotization
    Active Ingredient:
    Naloxone
    Formulation:
    Sustained release soft contact lenses

    An opioid injectable that saves lives and patient care costs.

    Background
    The national opioid epidemic remains a critical public health crisis in the US, representing the 7th leading cause of death nationwide. US state health departments purchase the largest quantities of naloxone - over 70% of the market - and distribute to over 4 million emergency first responders at local levels.
    Patient population
    Naloxone today (i.e.,NARCAN nasal spray) is typically first administered by emergency responders to overdose patients. Additional doses are often needed, and eventually lead to intravenous naloxone in an ER setting. A single injection product that accomplishes both goals WITHOUT hospitalization would be a best-in-class product that saves up to $3.8 billion in healthcare cost savings by replacing hospital visits, which are also resisted by addiction populations, or impractical in rural regions.
    Our solution
    Our injectable naloxone product will use one injection to provide both immediate reversal of opioid overdose, and a sustained NLX dose for protection over the following 8 – 10 hrs to prevent re-narcotization without high- or repeated-dose NLX that would lead to severe adverse events.
  • Dry eye CL
    Dry eye CL
    Dry eye
    Cyclosporine A
    Sustained release soft contact lenses
    Indication:
    Dry Eye
    Active Ingredient:
    Cyclosporine A
    Formulation:
    Cyclosporine A

    Treating a new global epidemic.

    Background
    Dry eye disease (DED) is among the most frequent causes for eye clinician visits.

    DED patients suffer from inadequate lubrication of the eye, which can occur in eyes that produce insufficient tear volume, or tears that evaporate too quickly. Increased inflammation can result, causing further complications and long-term damage. Furthermore, the increasing use of digital devices has been identified as a significant factor contributing to the rise in dry eye cases. Prolonged screen time is associated with reduced blink rates and incomplete blinking, leading to tear film instability and increased evaporation, which are key factors in the development of DED.

    Additionally, the blue light emitted by screens can penetrate deep into the eyes, potentially leading to the formation of free radicals and subsequent cellular damage. Primary treatments include tear film restoration using over-the-counter artificial tear drops, and immunomodulating therapy using prescription cyclosporine-A (CsA) eye drops.
    Patient population
    DED is one of the most common ocular diseases worldwide, with prevalence of up to 50% of the global, adult population and over 16 million Americans officially diagnosed.

    The CDC estimates that 45 million people in the US wear contact lenses. Further, dry eye and related symptoms of irritation are reported by 40% of these wearers, and 25% suffer from moderate to severe symptoms.
    Our solution
    Our DDCL administers the clinically proven dry eye therapeutic cyclosporine A for acute cases of dry eye, particularly among existing contact lens wearers.
  • Allergy DDCL
    Allergy DDCL
    Ocular Allergy
    Olopatadine
    Sustained release soft contact lenses
    Indication:
    Ocular Allergy
    Active Ingredient:
    Olopatadine
    Formulation:
    Sustained release soft contact lenses

    Allergy therapy that actually works.

    Background
    Allergic conjunctivitis (AC) is an inflammatory condition of the ocular conjunctiva resulting from exposure to pollen, animal dander, and environmental stimuli. Topical eye drops containing antihistamines are the primary treatment method, although limited by burst release, low bioavailability, and poor patient adherence. Further, eye drops are not practical for contact lens wearers as contact lenses prevent effective absorption of existing eye drop solutions targeting allergy-related symptoms.
    Patient population
    Over 20% of the U.S. – or approximately 66 million patients – are affected, with wearers of contact lenses (CL) particularly vulnerable due to allergen accumulation on the lens, and restricted tear exchange underneath its surface. Of the 45 million Americans that wear CLs, 40% suffer from allergies causing irritation and disruption of lens wear.
    Our solution
    Using our DDCL technology, we can produce sustained release of olopatadine (OPD) in order to more effectively treat AC. Further, production of our DDCL-OPD will be compatible with existing lens manufacturing operations, including all standard physical specifications and refractive capabilities of current commercial contact lenses, consituting a major improvement over both eye drops and available drug delivery lens technology.
  • Glaucome DDCL
    Glaucome DDCL
    Open-Angle Glaucome
    Bimatropost
    Sustained release soft contact lenses
    Indication:
    Open-Angle Glaucome
    Active Ingredient:
    Bimatropost
    Formulation:
    Sustained release soft contact lenses

    TBD

    Background
    Glaucoma is one of the leading causes of irreversible blindness in the United States, affecting nearly 3m Americans today while costing the US economy $2.86 billion every year in direct costs and productivity losses.
    Patient population
    By 2050, that number is expected to rise to over 6m due to the aging US population.
    Our solution (TBD)
    Using our DDCL technology, we can produce sustained release of olopatadine (OPD) in order to more effectively treat AC. Further, production of our DDCL-OPD will be compatible with existing lens manufacturing operations, including all standard physical specifications and refractive capabilities of current commercial contact lenses, consituting a major improvement over both eye drops and available drug delivery lens technology.
Have questions?

Drug Delivery for Contact Lenses

Lynthera’s drug delivery contact lens (DDCL) system employs a proprietary, sustained release technology in a silicone hydrogel (SiHy) lens to more effectively control release of ocular therapeutics.
More